Generic Uroxatral is used for treating symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It may also be used for certain conditions.
Other names for this medication:
Also known as: Alfuzosin.
Generic Uroxatral is an alpha-blocker. It works by blocking receptors in the lower urinary tract, causing smooth muscles in the bladder neck and prostate to relax. This relaxation improves urine flow and reduces the symptoms of BPH.
Generic name of Generic Uroxatral is Alfuzosin.
Brand name of Generic Uroxatral is Uroxatral.
Take Generic Uroxatral by mouth with food. Take with meal every day.
Swallow Generic Uroxatral whole. Do not break, crush, or chew before swallowing.
Take Generic Uroxatral on a regular schedule to get the most benefit from it.
If you want to achieve most effective results do not stop taking Generic Uroxatral suddenly.
If you overdose Generic Uroxatral and you don't feel good you should visit your doctor or health care provider immediately.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from moisture, light and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children in a container that small children cannot open.
The most common side effects associated with Uroxatral are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Do not take Generic Uroxatral if you are allergic to Generic Uroxatral components.
Do not take Generic Uroxatral if you're pregnant or you plan to have a baby, or you are a nursing mother. Generic Uroxatral can harm your baby.
Do not take Generic Uroxatral if you have moderate to severe liver disease.
Do not take Generic Uroxatral if you are taking an alpha-blocker (e.g., prazosin), an azole antifungal (e.g., ketoconazole), or an HIV protease inhibitor (eg, ritonavir).
Sit up or stand slowly, especially in the morning.
Avoid situations in which injury could occur due to fainting.
Keep Generic Uroxatral away from children and don't give it to other people for using.
Do not stop taking Generic Uroxatral suddenly.
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This study is a placebo-controlled comparison of the response to alfuzosin treatment for lower urinary tract symptoms (LUTS) in patients with and without metabolic syndrome (MetS).
The baseline symptom profile of patients who completed the study was identical to that of patients who dropped out (because the center resigned or during treatment). In the 4 patient populations, the percentage of patients per month who dropped out, experienced adverse effects, AUR and surgery were 0. 6-1.6, 0.1-0.5, 0.01-0.03, and 0.1-0.3%, respectively. The classes of symptom severity were not predictive for dropouts: 3.5, 12.6, 20, and 14.3% of the severe patients dropped out during treatment versus 4.2, 13.7, 22.9, and 14.0% of the moderate patients who dropped out up to 3, 12, 24, and 36 months, respectively. Safety was satisfactory regarding the number of adverse events and blood pressure measurement. No retrograde ejaculation was reported.
After a 1-month run-in period, 447 patients were randomly allocated in a double-blind placebo-controlled study to receive alfuzosin 10 mg once daily (n = 143), alfuzosin 2.5 mg thrice daily (n = 150) or placebo (n = 154) for 3 months. At inclusion, 46% of the randomised population had concomitant cardiovascular disease and 30% received an antihypertensive treatment. Uroflowmetry was performed close to trough plasma concentration of alfuzosin once daily to demonstrate the 24-hour coverage with this formulation.
1. We have previously shown that among alpha 1-adrenoceptor antagonists used or investigated for the treatment of benign prostatic hyperplasia, tamsulosin discriminates alpha 1-adrenoceptor subtypes in rat tissues whereas alfuzosin and naftopidil do not. We now expand these studies to additional drugs (doxazosin, terazosin) being used and/or investigated for this purpose, and have evaluated all of these drugs at cloned subtypes and in human prostate. 2. Competition binding studies were performed with [3H]-prazosin in membrane samples from rat spleen, kidney and cerebral cortex and human prostate and with cloned alpha 1-adrenoceptors expressed in COS cells. Doxazosin and terazosin did not discriminate alpha 1-adrenoceptor subtypes in rat kidney and cerebral cortex. In contrast, the subtypes present in the tissues were well discriminated by the alpha 1A-adrenoceptor-selective reference drug WB 4101. 3. Alfuzosin, doxazosin, naftopidil and terazosin did not discriminate cloned alpha 1-adrenoceptor subtypes transiently expressed in COS cells whereas tamsulosin and WB 4101 did. 4. In human prostate, alfuzosin, doxazosin, naftopidil and terazosin did not discriminate the alpha 1-adrenoceptor subtypes present in this tissue whereas tamsulosin and the alpha 1A-adrenoceptor-selective reference drugs WB 4101, phentolamine and 5-methylurapidil did. Based on data with the alpha 1A-adrenoceptor-selective drugs, human prostate contains alpha 1A- and alpha 1B-adrenoceptors in an approximate 70:30% ratio. 5. We conclude that tamsulosin, in common with WB 4101, but in contrast to alfuzosin, doxazosin, naftopidil, and terazosin is selective for alpha 1A-adrenoceptors which appear to dominate in the human prostate; the therapeutic relevance of this selectivity remains to be assessed in clinical studies.
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Acute urinary retention (AUR) in males is managed conventionally by hospital admission, alpha-adrenergic therapy, and trial without catheter. To reduce inpatient bed pressures, we set up a protocol to manage such patients in the community. We review our results in this paper. We performed a prospective study of male patients presenting to our acute admissions ward and Accident and Emergency department over 6 months. Patients with chronic urinary retention, macroscopic haematuria, sepsis, urinary tract infection, and/or serum creatinine >130 mmol/l were excluded from the study. Those enrolled were catheterised, commenced on alfuzosin (10 mg nocte), and discharged to the community. A trial without catheter (TWOC) was performed 5-7 days later. QoL/IPSS, peak flow rate, and residual volume assessment were performed following successful TWOC 3 months later. Thirty-one male patients with a median age of 69 years were studied and the median residual volume following catheterisation was 900 ml. The aetiology of AUR was benign prostatic hyperplasia (BPH) in 29 patients and constipation in the remaining 2 patients. TWOC was successful in 19 patients (61.3%) following first TWOC, 26 (83.9%) following second trial of voiding. The mean peak flow rate was 6.5 ml/sec and postvoid scan 165 ml, following an immediate TWOC. At 3 months follow-up, mean peak flow rate was 13.2 ml/sec, postvoid scan 26.5 ml, IPSS 4.5, and QoL score was 2. This study has shown that AUR can be managed safely and effectively in the community. Effective communication with the nurse urology specialist, general practitioner, and emergency department are crucial for the successful implementation of the protocol.
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Alpha-adrenoceptor antagonists (alpha-blockers) are efficacious in treating lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO), also termed symptomatic benign prostatic hyperplasia (BPH), causing bladder outlet obstruction (BOO). There is little difference among the various alpha-blockers in terms of efficacy in treating LUTS. However, conventional quinazoline derivatives such as terazosin, doxazosin and alfuzosin, originally developed for hypertension, have inherent cardiovascular extension effects, which influence the well being and safety of patients with LUTS by impairing physiological blood pressure (BP) control, even when their effect on unchallenged BP may be quite low. Preclinically, tamsulosin, a sulphonamide-substituted phenethylamine, has a relative selectivity for the alpha 1-adrenoceptors of the lower urinary tract. Clinically, this is associated with fewer cardiovascular extension effects with tamsulosin (modified release capsule) 0.4 mg once daily. This allows the use of convenient regimens of 0.4 mg tamsulosin administered once daily after breakfast from initiation of treatment without the need for 'step-up' increases of dose to avoid 'first-dose' hypotension. Extensive investigation, including multiple orthostatic stress testing (which otherwise is unusual in the characterization of alpha-blockers because of their inherent safety), confirms that tamsulosin 0.4 mg definitely carries a lower risk of impaired BP control.
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Evidence of the long-term efficacy and safety of alfuzosin treatment for LUTS indicative of BPH was examined.
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The role of alpha-lithics in the treatment of dysfunctional voiding in children is limited and of doubtful efficacy. It may be useful in patients with significant post-micturition residue.
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The included studies were randomized controlled trials involving men with symptomatic BPH treated with alfuzosin versus placebo or active control for at least 4 weeks.
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A systematic literature review was performed in December 2014 using Pubmed, Embase, and the Cochrane library databases to identify relevant studies. All randomized and controlled trials were included. A subgroup analysis was performed comparing Alfuzosin with control therapy on the management of distal ureteral stones.
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α1-Adrenoceptor blockers are the most frequently prescribed medical therapy in the treatment of lower urinary tract symptom suggestive of benign prostatic hyperplasia (LUTS/BPH). The purpose of this review is to highlight the evolution of adrenoceptor blockers with emphasis on newly approved drugs.
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The study subjects comprised 281 patients (60 with diabetes and 221 non-diabetics with clinically diagnosed BPH) who were treated with alpha1-blockers (doxazosin, terazosin, alfuzosin and tamsulosin). The international prostate symptom score (IPSS), bother score, maximum flow rate (Q(max)) and post-void residual urine volume (PVR) were determined at baseline and after treatment for a minimum of 6 months.
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The newly established method can be used in research and development of the enantiomers of three new drugs.
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The aim of the present study was the determination of formulation factors and the in vitro evaluation of an extended release dosage form of a freely soluble weakly basic drug (alfuzosin hydrochloride). Binary mixer of one hydrophilic polymer (hydroxypropylmethylcellulose) and one directly compressible Eudragit (RS PO) was used in tablets prepared by direct compression. The amounts of both polymers were taken as independent variables for the 3(2) Factorial design. The percent drug releases at 1, 6, 12 and 20 h were selected as responses. The main effect and interaction terms were quantitatively evaluated using mathematical model. Dissolution data were fitted to zero order, first order, and Higuchi's release kinetics to evaluate kinetic data. Both the diffusion and erosion mechanisms were responsible for drug release as shown by the power law. The release of Alfuzosin was prolonged for 20 h by binary mixer indicating the usefulness of the formulations for once daily dosage forms.
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Correlation between lower urinary tract dysfunction, urinary tract infection (UTI) and vesicoureteral reflux (VUR) is complex and well known. The impact of lower urinary tract dysfunction treatment on frequency of UTI in children with VUR was assessed in our study. Lower urinary tract dysfunction was diagnosed in 32 girls and 4 boys; 19 (53%) of them had VUR in 24 kidney units. All patients were on chemo-prophylaxis and were advised how to restore regular voiding and assume normal posture, in order to reach an optimal relaxation of the pelvic floor during voiding. Eight patients (42%) with signs of hyperactive bladder and/or small bladder capacity were administered anticholinergic-oxybutynin (0.2 mg/kg of body weight). Eleven patients (58%) with sign of bladder-sphincter dysfunction and/or residual urine volume over 20% were treated by alfa-blocker-alfuzosin (0.1 mg/kg of body weight). Four children with constipation were advised to use fiber-rich diet. During 12-mount follow-up, none had febrile UTI, and 7 (37%) had 1 to 3 UTI without temperature. In conclusion, conservative treatment of VUR should include chemo-prophylaxes, lower urinary tract dysfunction treatment, and treatment of constipation, what was confirmed by our study as well.
These data do not support the long term use of alpha-blockers in patients who voided successfully after acute urinary retention.
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To assess the efficacy and safety of a sustained-release (SR) formulation of alfuzosin, a selective alpha(1)-blocker, in patients with symptomatic benign prostatic hyperplasia (BPH).
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The ambulatory care program reduced the hospital admission rate and reduced cost without jeopardizing the TWOC success rate and safety in the management of patients presenting with AUR.
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Two single-dose, crossover studies were performed. In study 1, CV alpha1-adrenoceptor antagonism was assessed by measuring the inhibition of phenylephrine (PE)-induced increases in diastolic blood pressure (DBP) and total peripheral resistance (TPR) before and after dosing with placebo, tamsulosin OCAS, and alfuzosin XL in 18 young subjects. In study 2, orthostatic stress tests (OTs) were performed before and after dosing with tamsulosin OCAS and alfuzosin XL in 40 elderly subjects. Pharmacokinetics were assessed in both studies.
This European, randomized, double-blind, multicenter trial involved 1.051 patients with lower urinary tract symptoms related to benign prostatic hyperplasia. Patients received sustained release (SR) alfuzosin (n = 358), a selective alpha1-blocker given at a dose of 5 mg twice daily without dose titration; finasteride (n = 344), 5 mg once daily, or both drugs (n = 349), for 6 months. Primary efficacy criteria were symptomatic improvement (International Prostate Symptom Score: I-PSS) and maximum flow rate (Qmax). Safety was assessed by monitoring adverse events.
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In an open dose ranging study with random inclusion of placebo, alfuzosin (alpha 1-adrenoceptor antagonist) 1, 2.5 and 5 mg was administered to 6 healthy volunteers, 3 of the volunteers received 10 mg alfuzosin. Supine systolic blood (SBP) pressure was not reduced by alfuzosin although significant increases occurred in supine heart rate (HR) after 2.5 and 5 mg. In the standing position, SBP was reduced at 2 and 4 h with 5 mg alfuzosin; significant increases in HR occurred following 1, 2.5 and 5 mg at 2, 4, 6 and 8 h after administration. Exercise SBP was not reduced; diastolic blood pressure was significantly reduced at 4 and 6 h with 5 mg alfuzosin. More marked effects were seen in the 3 subjects who received 10 mg alfuzosin. After 1 and 5 mg, tmax ranged from 1-2 h; Cmax (4.1 to 20.8 ng.ml-1; AUC (0-24) 20 to 132 ng.ml-1.h (1 and 5 mg respectively) increased progressively with dose indicating dose dependent kinetics; no significant changes occurred in the visual analogue scale for sedation. A comparison of alfuzosin 5 mg, prazosin 1 mg and placebo each administered for 4 days, indicated that alfuzosin did not significantly reduce standing SBP on either Day 1 or Day 4; prazosin reduced SBP at 2 and 4 h on Day 1 and 6 h on Day 4 compared to placebo. Standing HR was increased by alfuzosin at 2 h on Day 1 and Day 4; increases occurred with prazosin at 2, 4, 6 and 8 h on Day 1 and 6 h on Day 4.(ABSTRACT TRUNCATED AT 250 WORDS)
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Both alfuzosin formulations significantly improved urinary symptoms versus placebo assessed using the International Prostate Symptom Score (alfuzosin 10 mg once daily: -6.9; alfuzosin 2.5 mg thrice daily: -6.4; placebo: -4.9, p = 0.005). Peak flow rate increased significantly with alfuzosin 10 mg once daily (+2.3 ml/s, p = 0.03 vs. placebo) and with alfuzosin 2.5 mg thrice daily (+3.2ml/s, p<0.0001 vs. placebo) compared to placebo (+1.4 ml/s). Overall both formulations of alfuzosin were well tolerated in comparison with placebo. In addition, vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation (6.3 vs. 9.4%, respectively). No first-day effect was reported with alfuzosin once daily and the effect on blood pressure did not differ from those observed in placebo, both in normotensive and hypertensive patients. No specific sexual dysfunction including ejaculation disorder was reported in the alfuzosin 10 mg once-daily group.
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Both finasteride and dutasteride reduced PSA and prostate volume significantly. The comparison between groups showed a more significant reduction of PSA (p=0.020) and prostate volume (p=0.052) in the dutasteride group. Other parameters did not differ significantly between the groups.
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The risk of mortality and long-term morbidity, including loss of sexual function, associated with surgical procedures for symptomatic benign prostatic hyperplasia (BPH) has prompted research into alternative medical therapies. Phytotherapy involves the use of herbal formulations, where the mechanisms of action are usually obscure and although studies have confirmed their effectiveness in symptom relief and improving quality of life (QOL), few placebo-controlled trials exist. Both the 5 alpha-reductase inhibitor finasteride and alpha 1-adrenoceptor antagonists (e.g. alfuzosin, doxazosin, prazosin, tamsulosin and terazosin) have been recommended as appropriate treatment options for patients with lower urinary tract symptoms (LUTS) associated with benign prostatic obstruction (BPO), and their efficacy has been proven in several placebo-controlled trials. Finasteride reduces the static component of BPO--by reducing the size of the prostate--and, as a result, symptom relief is slow (6-12 months) and is predominantly restricted to patients with large prostates (> 40 g). The alpha 1-adrenoceptor antagonists, on the other hand, reduce the dynamic component of obstruction--relaxation of smooth muscle in the prostate, urethra and bladder neck--and provide rapid symptom relief after only a few doses, relieving LUTS more effectively than finasteride and irrespective of prostate size. All of the various alpha 1-adrenoceptor antagonists provide effective and comparable relief of LUTS, and an improvement in bothersomeness and symptom-related QOL. However, it is also important that the therapy is fast acting and acceptable to the patient, in that it does not interfere with other medication or produce unpleasant side effects. These documented properties of the alpha 1A-adrenoceptor antagonists make them an ideal choice for the medical treatment of symptomatic BPH.
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